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RTF Template

Agency For Medicinal Products And Medical Devices Of Croatia

UNION FORMAT FOR A WHOLESALE DISTRIBUTION AUTHORISATION

Human medicinal products

1. Authorisation Number	:	UP/I-530-03/25-06/29; 381-13-08/353-25-03
2. Name of Authorisation Holder	:	Medorion d.o.o. (ORG-100038410 / LOC-100060397)
3. Address(es) of Site(s)	:	Ulica Janka Draskovica 5, Samobor, 10430, Croatia

4. Legally registered address of Authorisation Holder	:	Ulica Janka Draskovica 5, Samobor, 10430
5. Scope of authorisation (complete for each site under 4)	:	ANNEX 1
6. Legal basis of authorisation	:	Art. 77(1) of Directive 2001/83/EC
7. Name of responsible officer of the competent authority of the member state granting the wholesaling authorisation	:	Confidential, Confidential
8. Signature	:
9. Date	:	2025-07-23
10. Annexes attached	:	Annex 1 Scope of wholesale distribution authorisation Annex 2 (Optional) Address(es) of contract wholesale distribution sites and their authorisation number Annex 3 (Optional) Name(s) of responsible person(s) Annex 4 (Optional) Date of Inspection on which authorisation was granted Annex 5 (Optional) Additional provisions based on national requirements

ANNEX 1

SCOPE OF WHOLESALE DISTRIBUTION AUTHORISATION

Name and address of the site: Medorion d.o.o.

(ORG-100038410 / LOC-100060397)

, Ulica Janka Draskovica 5, Samobor, 10430, Croatia

Human medicinal products

1. MEDICINAL PRODUCTS

1.1. with a Marketing Authorisation or registration in EEA country(s)

1.2. without a Marketing Authorisation or registration in the EEA and intended for EEA market*

2. AUTHORISED WHOLESALE DISTRIBUTION OPERATIONS

2.1. Procurement

2.3. Supply

2.4. Export

3. MEDICINAL PRODUCTS WITH ADDITIONAL REQUIREMENTS

3.2. Products requiring low temperature handling

3.2.1. Temperatures between 2 to 8 °C

3.2.2. Other temperatures: (please specify) -25 to -15

3.3. Other products: (please specify here or make a reference to Annex 5) Please see Any restrictions or clarifying remarks (for all users)

Any restrictions or clarifying remarks (for all users): Medicinal products from section 3.3 are: Medicinal products derived from blood, Immunological medicinal products and Biological medicinal products.

2.2 Holding is conducted in a contracted warehouse at MEDIKA d.d., Strojarska cesta 9b, 10361 Sesvetski Kraljevec, Croatia (ORG-100006010/ LOC-100084086).

*Art. 5 of Directive 2001/83/EC, Art. 83 of Regulation (EC) 726/2004 and Art. 110 of Regulation 2019/6.

Union Format for a Wholesale Distribution Authorisation	UP/I-530-03/25-06/29; 381-13-08/353-25-03
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